P025 Real-world effectiveness of biologic therapies among patients with moderate-to-severe ulcerative colitis in the United States. (July 2019) - Erin, Comerford
Abstract : BACKGROUND: Treatment goals for ulcerative colitis (UC) focus on inducing a response and maintaining long-term disease remission. The aim of this study was to describe the real-world effectiveness of biologic therapies, as defined by the need for concomitant steroids and UC-related hospitalizations. METHODS: This retrospective analysis used the PharMetrics Plus claims data from January 1, 2013 to October 1, 2017. Patients aged ≥18 years with UC (ICD9:556.* or ICD10 K51.*) who newly initiated biologic therapy (adalimumab [ADA], infliximab [IFX], vedolizumab [VEDO], golimumab [GOL]) were included. Patients had to have at least 12 months of continuous enrollment prior to (pre-index) and after (post-index) their first biologic drug claim (index). Patients with Crohn's disease or a history of biologic therapy in the pre-index period were excluded. Steroid use, dosage, and duration were reported descriptively. Time spent steroid free (allowing for an initial 14 week steroid tapering period) and hospitalizations in the post-index period were used as measures of real-world effectiveness. RESULTS: N = 3, 595 patients with UC were included (51.7% male; age = 42.4 years [SD = 13.6]; disease duration = 1.3 years [SD = 1.0]) with the following treatments at index: N = 2, 055 on ADA, N = 1, 218 on IFX, N = 152 on GOL, and N = 170 on VEDO. Most patients (84.3%) had used steroids in the pre-index period. Ignoring steroid use during the tapering period, a total of 42.4% of patients were steroid-free in the post-index period. For the 57.6% of patients who used steroids, the mean time to first steroid was 202.1 days (SD = 72.2). This varied by index therapy: ADA = 58.7% used steroids and mean time to first steroid was 201 days, IFX = 55.3% and 207 days, GOL = 66.4% and 181 days, and VEDO = 52.9% and 209 days. The type of steroids use in the post-index period also varied across index biologic treatment. For example, 41.5% of patients treated with ADA used prednisone compared with IFX = 36.7%, GOL = 47.4%, and VEDO = 26.5%. A total of 13.2% of patients had a UC-related hospitalization in the post-index period with, among those hospitalized, an average of 11.4 total days spent in hospital during the post-index period (SD = 14.1). Unadjusted all-cause hospitalization rates and total days hospitalized by treatment were as follows: ADA = 14.0% were hospitalized with 10.4 total days spent in hospital (SD = 13.6); IFX = 19.5% and 11.1 total days (SD = 14.1); GOL = 14.5% with 6.2 total days (SD = 6.6); VEDO = 11.2% with 8.2 total days (SD = 6.5). CONCLUSION(S): Almost 60% of UC patients who initiate their first biologic therapy rely on steroids within the first 12 months. A number of patients also experience extended UC-related hospitalization stays. These results suggest an ongoing challenge in managing these patients.